Benutzer-Zertifikate

Zur Erstellung ICH-konformer Studienberichte anhand von Texttemplates und des ICH-Berichtsmanagers. Folgende Leistungen werden von idv hierzu erbracht:

• Upgrade des ICH-Studymanagers mit kompletter Berichtsvorlage und Handlungsanweisungen
• Tutorial mit Übungsdaten zur Auswertung und Berichtserstellung gemäß GCP
• Zertifizierungsdatensatz zur selbstständigen Auswertung und Berichtserstellung.
• Annahme und Überprüfung der Ergebnisse
• Zertifikatserteilung 'Master of Clinical Trials' für das jeweilige Gebiet.

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Disposition of Patients and Study Conduct

• 'Disposition of Patients and Study Conduct' (text, flowchart, tables).
• Dropouts. Protocol violations (criteria for inclusion and exclusion, schedule, compliance, classification as minor, major, severe).
• Operationalizing of the datasets / populations (safety, ITT, full analysis set, PP).
• Evaluation of compliance.
• Time window for doctors' visits, 'exposure time'.
• Complete presentation scheme with currently recommended definitions.

Baseline Characteristics

• Accurate accomplishment of studies by means of non-parametric and classical descriptive methods.
• Graphical presentation of the results by means of effect sizes and confidence intervals.
• Validated import of tables and figures into the Clinical Study Report.
• Identification of inhomogeneities.
• Correct description and interpretation of the results.

Efficacy Criteria: Descriptive Analysis

• Accurate accomplishment of modern descriptive analyses regarding continuous data, score values and binary data.
• Validated import of the results into the Clinical Study Report.
• Creation of graphical analyses in accordance with the state-of-the-art biometry.
• Description and interpretation of methods used and results given in the Clinical Study Report.

Efficacy Criteria: Teststatistical Analysis

• Template for modern robust / non-parametric procedures in accordance with ICH E9.
• Test for difference and test for equivalence / non-inferiority.
• Effect size and confidence intervals.
• Tables and graphical representations.
• Correct multi-center analyses and adjustments with respect to baseline-inhomogeneities.
• Description of the methods and correct interpretation of the results.

Evaluation of Laboratory Values

• Generating tables (absolute, changes from baseline, percent changes, treatment of abnormal values, establishing of sign tests, shift tables, graphics).
• Correct description of methods.
• Standardized presentations/interpretation of the results in the study report according to ICH E3.

Rescue Medication

• How to detect and evaluate a study nuisance factor like rescue medication.

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Weitere Zertifikate gibt es auch für REPORT und TESTIMATE